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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
36 apple ridge road
danbury, CT 06810
PMA NumberP010025
Supplement NumberS017
Date Received11/05/2009
Decision Date12/23/2009
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the selenia dimension 2d ffdm to be used in a mobileenvironment with the following design changes:1) acquisition station:a) the acquisition station monitor will be mounted on a fixed mount mechanism that allows positioning of the monitor via a spring loaded locking device. The mobile system monitor can be fixed mounted on the left,right or center position. B) the keyboard tray has been secured with a spring loaded latching mechanism to prevent movement during transport. C) the bar code scanner can be mounted either on the left or right side of the monitor as needed in the mobile application. D) the x-ray shield is replaced with non attenuating, cosmetic clear plastic (as cover gap fillers). 2) gantry:a) the vertical travel assembly (vta) has been configured with an electromagneticbrake to prevent unwanted travel during transport. B) a mounting feature has been added to the top section of the gantry frame forsupplemental support in a coach/van. C) the upper movement limit of the c-arm is now configurable from 6' 10" to 7' 10" to allow for lower ceilings in a coach/van. 3) instructions for use and qc manual:a mobile addendum includes current user manual with added warnings and instructionsregarding mobile use. In addition, the mobile addendum includes instructions to the user on the qc tests that are required to be performed prior to clinical use after movement.